MAUDE Adverse Event Report: ARTHREX, INC. AVL 4.5MM INFERIOR DRILL, MODULAR; POWERED SURG ORTHOPEDIC INSTR

Model Number	AVL 4.5MM INFERIOR DRILL, MODULAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/6/2023, it was reported by a sales representative via sems that an ar-9239ag inferior drill was broken, no additional information was provided.No case involvement.On 7/21/2023, the sales representative stated via email that the device had been discarded by the technician during the case.Additional information has been requested.On 7/21/2023, the sales representative provided the following information via email: this event occurred during a right total shoulder arthroplasty procedure.The instrument broke when drilling the inferior hole on the glenoid for the augmented vaultlock implant.All fragments were retrieved, and they used a drill from another tray.There were no adverse reactions or events from the patient.The case was completed as normal but with the backup drill bit.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are over-torquing/over-engaging the device during insertion.

• Brand Name: AVL 4.5MM INFERIOR DRILL, MODULAR
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17458235
• Report Number: 1220246-2023-07419
• Device Sequence Number: 7237096
• Product Code: HWE
• UDI-Device Identifier: 00888867350489
• UDI-Public: 00888867350489
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AVL 4.5MM INFERIOR DRILL, MODULAR
• Device Catalogue Number: AR-9239AG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown